One diabetes drug gets new indication, another gets new warning labeling

Details on the latest recalls, warnings, and approvals.

Recalls and warnings

A label change for pioglitazone-containing medications (Actos, Actoplus Met, Actoplus Met XR, Duetact, Oseni) regarding the drug's association with risk of bladder cancer. Although labels of these drugs have warned about this risk since 2011, the FDA has approved updated labels that will describe the additional studies it recently reviewed. The agency recommends against using the diabetes drug in patients with active bladder cancer and urges clinicians to carefully consider risks and benefits before using it in patients with a history of bladder cancer.

Photo by Thinkstock
Photo by Thinkstock

Removal of warnings on the risk of serious mental health side effects from two smoking-cessation medications. The black-box warning label will be removed from varenicline (Chantix), and the boxed warning for bupropion (Zyban) will be updated. The FDA has determined that the risks of serious side effects on mood, behavior, or thinking are lower than previously suspected, based on its review of a large clinical trial the agency required the drug companies to conduct. The risk of mental health side effects still exists, especially in patients currently or formerly treated for mental illnesses, but most people who experienced these side effects did not have serious consequences (e.g., hospitalization).

A class I recall of 1,000 Centurion Convenience Kits containing multi-med single lumen catheters. Excess material may remain at the catheter tip and could separate from the catheter during use and enter the patient's bloodstream. Recalled kits were distributed between May 23 and Oct. 18, 2016.

A recall of all unexpired 50-mm 0.2-micron filters, used during the compounding of solutions, due to the potential presence of particulate matter and of a missing filter support membrane. Recalled products were distributed globally between Aug. 12, 2013, and June 20, 2016, and have been discontinued for unrelated reasons.

A class I recall of the adaptor and light adaptor that power DePuy Synthes Small Battery Drive and Small Battery Drive II surgical power tool systems. The 451 recalled adaptors, distributed between January 2006 and June 2016, may produce extreme internal pressure, which may cause the devices to explode.


A new indication for empagliflozin (Jardiance) to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease. In a postmarketing clinical trial of more than 7,000 patients with type 2 diabetes and cardiovascular disease, the drug reduced the risk of cardiovascular death compared to placebo when added to standard-of-care therapies for diabetes and atherosclerotic cardiovascular disease. The most common side effects of empagliflozin are urinary tract infections and female genital infections, and it can also cause dehydration, hypotension, acute kidney injury, increased cholesterol, and ketoacidosis.

Rucaparib (Rubraca) to treat advanced ovarian cancer. The drug is indicated for women who have been treated with two or more chemotherapies and whose tumors have a deleterious BRCA mutation, as identified by FoundationFocus CDxBRCA, an FDA-approved companion diagnostic test. The safety and efficacy of the orphan drug, which received accelerated approval, were shown in two single-arm clinical trials involving 106 participants. In the trials, 54% of those who received the drug experienced complete or partial shrinkage of their tumors, a response rate that lasted a median of 9.2 months. Common side effects include nausea, fatigue, vomiting, anemia, abdominal pain, dysgeusia, constipation, decreased appetite, diarrhea, thrombocytopenia, and dyspnea. Serious risks include myelodysplastic syndrome, acute myeloid leukemia, and fetal harm.

Crisaborole (Eucrisa) ointment to treat mild to moderate atopic dermatitis. Patients topically apply the phosphodiesterase-4 inhibitor twice daily. In two placebo-controlled trials with a total of 1,522 participants ages 2 to 79, those receiving the ointment achieved greater response with clear or almost clear skin after 28 days of treatment. The ointment is contraindicated in patients who have had a hypersensitivity reaction to crisaborole. The most common side effect is pain (e.g., burning, stinging) at the application site.

Autologous cultured chondrocytes on porcine collagen membrane (Maci) for the repair of symptomatic, full-thickness cartilage defects of the knee in adult patients. This is the first FDA-approved product that applies the process of tissue engineering to grow cells on scaffolds using healthy cartilage tissue from the knee. Safety and long-term efficacy were shown in a two-year clinical trial of 144 patients. The most common side effects were joint pain, common cold-like symptoms, headache, and back pain.